- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02816957
Benefits of Nigella Sativa in Children With Beta Thalassemia Major (Nigella)
Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study will be carried on children patients with β- thalassemia major attending The Hematology Unit of Pediatric Department at Tanta University Hospital. patients are divided into 2 groups: patients in the control group, patients in the treatment group that will receive nigella sativa powder for 3 consecutive months. Then Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.
Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, treatment of the causes of hemolysis and other therapeutic benefits of Nigella sativa in those patient.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Nahed Mohamed Habas, MD
- Phone Number: 01010560350
- Email: nahedhablas79@gmail.com
Study Contact Backup
- Name: Nahed moh Hablas, MD
- Phone Number: 00201010560350
- Email: nahedhabls79@gmail.com
Study Locations
-
-
Gharbia
-
Tanta, Gharbia, Egypt, 0000
- Recruiting
- Faculty of Medicine- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Thalassemia with iron overload
Exclusion Criteria:
- Thalassemia complicated with diabetes mellitus or hepatitis
- Patients who discontinue treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: patients receiving Nigella
40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.
|
nigella sativa powder (2 gm/day) for 3 consecutive months.
|
NO_INTERVENTION: patients not received nigella as controls
40 patients in the control group will not receive nigella sativa and continued on the usual chelators
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
malondialdehyde
Time Frame: 3 months
|
nmol serum level of malondialdehyde (nmol per liter)
|
3 months
|
cluster of differentation4 and 8(CD4 and CD8)
Time Frame: 3 months
|
CD4 and CD8 cell per cmm
|
3 months
|
total antioxidant
Time Frame: 3 months
|
total antioxidant(mmol per liter)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum iron
Time Frame: 3 months
|
microgram per dl
|
3 months
|
total iron binding capacity
Time Frame: 3 months
|
microgram per dl
|
3 months
|
serum ferritin
Time Frame: 3 months
|
ng per ml
|
3 months
|
complete blood count
Time Frame: 3 months
|
complete blood count
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohamed Ramadan ELshanshory, prof, Professor of Pediatrics
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30794l03l16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nigella Sativa With Beta Thalassemia Major
-
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